MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - MR MAGNETOM VERIO DOT UPGRADE; SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL

Model Number	10684334
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that a serious injury occurred during a patient examination on (b)(6) 2023.The mri technician sustained a serious injury due to an oxygen cylinder becoming stuck to the magnet of the magnetom verio system.The mri technician sustained a severe abdominal injury during this event and had to undergo life-saving emergency surgery to treat the injury.As of march 13, 2023, siemens has received additional information stating the injured mri technician is still in the facility's intensive care unit.The patient present during the event on (b)(6) 2023 was not injured.
Additional Manufacturer Narrative
Siemens has initiated a detailed investigation of the reported event.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Additional Manufacturer Narrative
Siemens healineers completed the investigation of the reported issue.As previously reported, an mri technician sustained an abdominal injury during this event and had to have an emergency surgery performed to save their life.As per the additional information from (b)(6) 2023 the injured mri technician is still in the icu.We have requested an update on the current health status of the injured mri technician and received a reply.It was detailed that severe injuries were multiple minor fractures and internal organ injury.The technician has been discharged from the hospital and has been recovering well in their own residence.The hospital did not disclose details of the treatment.This incident was not related to a malfunction of the device.A ferromagnetic oxygen tank was taken into the magnet room and was attracted to the magnet.We assessed the complained event and concluded that the cause of this event was the introduction of ferromagnetic pieces into the mr examination room and therefore a user error.Due to the strong magnetic field, special safety measures have to be adhered to in order to prevent injuries.Therefore, the corresponding magnetom operator manual and the magnetom system owner manual provide clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.However, the responsibility to instruct personnel and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The manuals state that only equipment specified or recommended for use in the controlled area (mr examination room) shall be used.The introduction of ferromagnetic objects into the magnetic field is contrary to the statements given in the operating instructions.Furthermore, special warning signs are posted at the entrance of the controlled access area (magnet room).

• Brand Name: MAGNETOM VERIO DOT UPGRADE
• Common Device Name: SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16551708
• Report Number: 3002808157-2023-66766
• Device Sequence Number: 14686803
• Product Code: LHN
• UDI-Device Identifier: 04056869006680
• UDI-Public: 04056869006680
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10684334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male